ACTRN12617000951358
Active, not recruiting
Phase 2
ymph node grafting for upper limb lymphoedema following breast cancer treatment
Mr Winston McEwan0 sites65 target enrollmentJuly 4, 2017
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mr Winston McEwan
- Enrollment
- 65
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Ipsilateral upper limb lymphoedema of severity stage one (but requiring the regular use of a compression garment) or stage two (ISL staging system).
- •2\) Meets definition of lymphoedema: has either a 200 ml inter\-limb volume difference, or a 10% difference in limb volume.
- •3\) Previously treated stage 1\-3 breast cancer.
- •4\) Undergone local standard lymphoedema therapy for at least three months prior to enrolment and continued participation with techniques.
- •5\) Fit for operative procedure.
Exclusion Criteria
- •1\) Metastatic breast cancer;
- •2\) Past history of other malignancy with potential lymphatic drainage to either axillae;
- •3\) BMI \>40;
- •4\) Current smoker;
- •5\) Congestive heart failure;
- •6\) low serum albumin (\<32g/L);
- •7\) Poorly controlled diabetes (bA1c \> 70mm/L);
- •8\) Steroid medication;
- •9\) Previous lymph node grafting.
Outcomes
Primary Outcomes
Not specified
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